FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Klassic HD Hip System
K Number: K161073
·
Decision Oct 19, 2016
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
8
Review Days
184
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Basic Information
- Device Name
- Klassic HD Hip System
- K Number
- K161073
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Total Joint Othopedics, Inc.
- Date Received
- April 18, 2016
- Decision Date
- October 19, 2016
- Product Code
- LPH
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | FDA class 2 | Orthopedic |
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Other Clearances by Total Joint Othopedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243991 | Klassic Knee System - Revision Tibial Baseplate | Mar 24, 2025 | Substantially Equivalent |
| K232414 | Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post | Sep 8, 2023 | Substantially Equivalent |
| K230537 | Klassic Knee Revision System | May 19, 2023 | Substantially Equivalent |
| K213580 | Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length | Dec 3, 2021 | Substantially Equivalent |
| K191399 | BIOLOX CONTOURA Ceramic Femoral Head | Aug 28, 2019 | Substantially Equivalent |
| K171962 | Klassic HD® Hip System | Jul 24, 2017 | Substantially Equivalent |
| K143407 | Klassic HD Hip System | Dec 23, 2014 | Substantially Equivalent |